Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product U
Recalled Product
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Hazard / Issue
A potential bias was identified with certain kits compared to the internal standards.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211
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